Off-Label Use Increases Risks of Risperdal Side Effects

Doctors generally rely on U.S. Food & Drug Administration’s approval for a medication when they choose to prescribe it for “indicated uses,” or those for which the agency has seen adequate clinical information. Yet it is still common in the psychiatric and other medical fields for doctors to use medications for unapproved, or “off-label,” needs of patients. This off-label use of Risperdal may have played a significant role in the growing number of lawsuits over Risperdal side effects like male breast growth, or “man boobs.”

Risperdal was approved for use in adults with bipolar disorder and schizophrenia in the early 1990s, but drug maker Johnson & Johnson recently settled with the FDA regarding its alleged over-promotion of the atypical antipsychotic to children. Many of those patients now say they have experienced Risperdal “man boob” side effects because their doctors followed the recommendations of sales representatives.

The drug was finally approved for use in the treatment of bipolar disorder and schizophrenia in youths aged 10 to 17 in 2007, but prior to that there were no published warnings regarding the effect the medication had on adolescent male breast growth.

It has been alleged that some companies, although not Johnson & Johnson specifically, took advantage of the relatively lax marketing regulations of the 2000s as a way to conduct pre-trial studies by using patients undergoing treatment with off-label medications as guinea pigs before they began clinical trials in-house. There is no detailed evidence of Johnson & Johnson promoting the drug for this usage.

Still, by pushing its usage in children without knowing of the age-specific problems regarding Risperdal man boob side effects, many teens have found that they have been permanently disfigured as a result of using the medication.

If you took Risperdal between the ages of 10 and 18 and developed “man boobs,” nipple pain, nipple discharge or other similar side effect, you may be eligible to pursue damages. The first step is to find out whether or not the facts of your case are sufficient to file a Risperdal lawsuit. Do so with a no-cost eligibility review available to those who submit their information through the form found at the Risperdal Side Effects, Male Breast Growth Class Action Lawsuit Investigation today. More than 400 cases are currently pending against Johnson & Johnson regarding their marketing of this atypical antipsychotic and how it warned of potential side effects.